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Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01688726
First Posted: September 20, 2012
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
September 17, 2012
September 20, 2012
November 11, 2014
November 18, 2014
November 19, 2014
December 2012
November 2013   (Final data collection date for primary outcome measure)
Mean Bulbar Conjunctival Staining [ Time Frame: Month 1 ]
The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.
Bulbar conjunctival staining [ Time Frame: One month ]
The conjunctival staining present in the bulbar area will be evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. The extent of true staining (the number of puncti and their individual size and the total area of coverage) will be measured and compared to the total area.
Complete list of historical versions of study NCT01688726 on ClinicalTrials.gov Archive Site
  • High Contrast logMAR Time Controlled Visual Acuity (TCVA) [ Time Frame: Month 1 ]
    TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
  • Non Invasive Tear Film Break-up-time (NIBUT) [ Time Frame: Month 1 ]
    NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.
  • High Contrast logMAR Time Controlled Visual Acuity (TCVA) [ Time Frame: One month ]
    This visual acuity test will be carried out prior to eyedrop instillation and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. For each acuity level, 20 single optotypes will be presented at 4 meters under high illumination, and the percentage of correctly identified will constitute the score.
  • Non Invasive Tear Film Break-up-time (NIBUT) [ Time Frame: One month ]
    This assessment will be carried out prior to eyedrop instillation and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film, as observed with a specialized illumination source, will be recorded.
Not Provided
Not Provided
 
Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
Evaluation of SYSTANE® BALANCE on Conjunctival Staining (CS) Visual Performance (VP) and Tear Film Kinetics (TFK) in Dry Eye Subjects With Lipid Deficiency
The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Dry Eye Syndrome
  • Lipid Deficiency
  • Other: SYSTANE® BALANCE eyedrops
  • Other: Minims® Saline 0.9% eyedrops
  • Experimental: SYSTANE BALANCE
    SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month
    Intervention: Other: SYSTANE® BALANCE eyedrops
  • Active Comparator: Minims Saline
    Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month
    Intervention: Other: Minims® Saline 0.9% eyedrops
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
November 2013
November 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-contact lens wearer;
  • Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
  • Lipid deficiency;
  • Best visual acuity of 6/9 or better in each eye;
  • Willingness to adhere to the instructions set in the clinical protocol;
  • Signature of the subject informed consent form;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Use of systemic medication which might produce dry eye side effects;
  • Systemic disease which might produce dry eye side effects;
  • Active or recent ocular inflammation or infection;
  • Use of ocular medication;
  • Significant ocular anomaly;
  • Previous ocular surgery;
  • Previous use of Restasis;
  • Any medical condition that might be prejudicial to the study;
  • Pregnant or lactating;
  • Other protocol-defined exclusion criteria may apply.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United Kingdom
 
NCT01688726
A00977
No
Not Provided
Not Provided
Alcon Research
Alcon Research
Not Provided
Principal Investigator: Michel Guillon, PhD, FCOptom, FAAO, CCTI OTG Research & Consultancy
Alcon Research
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP